Madsen OTOflex 100 User manual

User Manual
Part No. 7-50-00000
Doc. No. 7-50-0000/U2

Copyright notice
No part of this User Manual or program may be reproduced, stored in a retrieval system, or trans-
mitted, in any form or by any means, electronic, mechanical, photocopying, recording, or other-
wise, without the prior written consent of GN Otometrics A/S.
Copyright©
2003, GN Otometrics A/S
Printed in Denmark by GN Otometrics A/S, Denmark
All information, illustrations, and specifications in this manual are based on the latest product in-
formation available at the time of publication. GN Otometrics A/S reserves the right to make
changes at any time without notice.
Technical support
Please contact your supplier.

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Contents
1 Introduction
1.1 The OTOflex 100 .......................................................................................................................... 7
1.2 The OtoDiagnostic Suite PC software ........................................................................................ 8
1.3 About this manual....................................................................................................................... 8
1.4 Typographical conventions......................................................................................................... 9
1.4.1 The use of WARNING, CAUTION and NOTE .................................................................. 9
1.4.2 Navigation ....................................................................................................................... 9
2 When you receive the OTOflex 100
2.1 Unpacking.................................................................................................................................. 11
2.2 Storing the OTOflex 100 ........................................................................................................... 11
2.3 Views of the OTOflex 100 ......................................................................................................... 12
2.3.1 Front view...................................................................................................................... 12
2.3.2 Top view ........................................................................................................................ 12
2.3.3 Bottom view .................................................................................................................. 13
2.3.4 Reverse side view ..........................................................................................................13
2.3.5 The charger.................................................................................................................... 14
2.4 Probe .......................................................................................................................................... 15
2.5 Assembly and installation ......................................................................................................... 15
2.5.1 Location ......................................................................................................................... 15
2.5.2 Powering the OTOflex 100 ........................................................................................... 16
2.5.3 The charger.................................................................................................................... 17
2.5.4 Connecting the OTOflex 100 probe and insert phone ............................................... 18
2.6 Display & keypad ....................................................................................................................... 21
2.6.1 Keys, terms, functions ................................................................................................... 21
2.6.2 Entering and editing data and settings....................................................................... 21
2.7 Device setup............................................................................................................................... 22
3 Preparing for testing
3.1 Preparing the test environment ...............................................................................................23
3.1.1 The physical environment............................................................................................. 23

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3.1.2 Hygienic precautions..................................................................................................... 23
3.2 Preparing the probe.................................................................................................................. 23
3.2.1 Preparing for screening ................................................................................................ 23
3.2.2 Preparing for diagnostic and clinical testing............................................................... 25
3.3 Preparing the OTOflex 100 ....................................................................................................... 26
3.3.1 Probe test....................................................................................................................... 26
3.3.2 Fitting the eartip on the probe .................................................................................... 27
3.3.3 Selecting a patient ........................................................................................................28
3.3.4 Selecting the user.......................................................................................................... 29
3.3.5 Selecting the test type .................................................................................................. 30
3.4 Preparing the patient................................................................................................................ 30
3.4.1 Selecting the ear and fitting the probe with eartip in the ear canal ........................ 31
4Tests
4.1 Starting up the test ................................................................................................................... 33
4.2 Tympanometry .......................................................................................................................... 34
4.2.1 Tympanometric sweep.................................................................................................. 34
4.3 Reflex testing............................................................................................................................. 36
4.3.1 Acoustic Reflex Threshold............................................................................................. 37
4.3.2 Acoustic Reflex Decay ................................................................................................... 38
4.3.3 Eustachian Tube Function - Perforated (ETF-P) ........................................................... 41
5 Setup
5.1 Measurement settings............................................................................................................... 43
5.1.1 Changing measurement settings ................................................................................. 43
5.1.2 Uploading measurement settings to the OtoDiagnostics Suite ................................. 44
5.1.3 Tympanometric settings ............................................................................................... 44
5.1.4 Reflex Threshold settings.............................................................................................. 46
5.1.5 Reflex Decay settings .................................................................................................... 49
5.2 Device settings........................................................................................................................... 50
5.3 Sequence setup.......................................................................................................................... 51
5.3.1 Procedure options ......................................................................................................... 51
6 Viewing results
6.1 Viewing all results ..................................................................................................................... 53
6.2 Viewing current results ............................................................................................................. 53

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7 Printing results
7.1 Printing a single-page report ................................................................................................... 55
7.2 Printing current results ............................................................................................................. 55
8 Service and Maintenance
8.1 Equipment failure ..................................................................................................................... 57
8.2 Service and repair...................................................................................................................... 57
8.3 Maintenance.............................................................................................................................. 58
8.3.1 Calibration ..................................................................................................................... 58
8.3.2 Probe cleaning and maintenance ................................................................................ 58
8.3.3 Cleaning and disinfecting the probe tip...................................................................... 58
8.3.4 Cleaning and disinfecting the test cavity .................................................................... 61
8.3.5 Changing the acoustic filter ......................................................................................... 61
8.3.6 Cleaning the OTOflex 100 ............................................................................................ 62
8.3.7 Eartips ............................................................................................................................ 63
8.3.8 Disposal of disposable articles...................................................................................... 63
8.3.9 Batteries and charger.................................................................................................... 63
8.3.10 Safety information ........................................................................................................64
8.3.11 Environmental protection ............................................................................................ 64
9 Troubleshooting
10 Safety
10.1 Symbols used ............................................................................................................................. 67
10.1.1 OTOflex 100 symbols..................................................................................................... 67
10.1.2 Charger unit symbols .................................................................................................... 68
10.2 Warning notes ........................................................................................................................... 69
10.2.1 OTOflex 100 warning notes.......................................................................................... 69
10.2.2 Charger unit warning notes ......................................................................................... 71
10.3 Manufacturer............................................................................................................................. 71
10.3.1 Responsibility of the manufacturer ............................................................................. 71
11 Technical Specifications
11.1 Otoflex 100 ................................................................................................................................ 73

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11.1.1 Compliance measuring system ..................................................................................... 73
11.1.2 Acoustic Reflex .............................................................................................................. 73
11.1.2.1 Contra lateral Stimulation.......................................................................... 73
11.1.2.2 Ipsilateral Stimulation ................................................................................ 74
11.1.3 Air pressure system .......................................................................................................74
11.1.4 Data interface................................................................................................................ 74
11.1.5 Type identification ........................................................................................................ 75
11.1.6 Power supply ................................................................................................................. 75
11.1.7 Dimensions and weight ................................................................................................ 75
11.2 Charger unit............................................................................................................................... 75
11.2.1 Type identification ........................................................................................................ 75
11.2.2 Power supply ................................................................................................................. 75
11.2.3 Dimensions and weight ................................................................................................ 76
11.3 Operating mode ........................................................................................................................ 76
11.4 Operating environment ............................................................................................................ 76
11.5 Transport and storage............................................................................................................... 76
11.6 Miscellaneous ............................................................................................................................ 76
11.7 Standards ................................................................................................................................... 77
11.8 Standard and optional accessories ...........................................................................................77
12 Glossary
12.1 Clinical Terminology.................................................................................................................. 79

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GN Otometrics A/S 7
1 Introduction
Thank you for purchasing the OTOflex 100.
This manual is your guide to the use and maintenance of your
OTOflex 100.
We strongly recommend that you read it carefully before using your
OTOflex 100 for the first time.
We also recommend that you take particular note of the cleaning and
maintenance instructions. Failure to use and maintain the OTOflex
100 correctly may void your warranty.
1.1 The OTOflex 100
Intended use
The OTOflex 100 is an audiodiagnostic device intended for clinical,
diagnostic and screening tympanometry and reflex measurements
performed by audiologists, ENTs and other health care profession-
als. It is designed for use on infants, children and adults, and is light-
weight, fast, reliable, and easy to use.
The OTOflex 100 uses technologies which are highly effective for
clinical and screening purposes. Tympanometry and acoustic reflex
measurements measure the mechanic response of the middle ear
and determines whether the related physiological structures are
functioning correctly or not.
The OTOflex 100 probe is extremely lightweight (only 4.5 grams),
and comes with comfortable, easy to insert probe tips. This makes it
ideal for use with children and adults.
The OTOflex 100 can be configured for a wide variety of tests, and it
can be operated entirely manually or programmed for the user’s
own combination of manual and automatic operation. In user-pro-
grammable tests the user can select the default parameters of a par-
ticular test, and combine tests to form a sequence of preset tests.

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User Manual OTOflex 100
1.2 The OtoDiagnostic Suite PC software
The OTOflex 100 is designed for operating with the OtoDiagnostic
Suite. You can:
• Upload data to and download data from the OtoDiagnostic
Suite.
• Define your measurement settings in the OtoDiagnostic Suite
and download them to the OTOflex 100.
•OperatetheOTOflex 100 independently of the OtoDiagnostic
Suite, and subsequently transfer test results and patient data.
Wherever relevant, references to the OtoDiagnostic Suite is listed in
this User Manual. For specific instructions on how to use the OtoDi-
agnostic Suite, please see the OtoDiagnostic Suite User Manual.
1.3 About this manual
This User Manual contains a description of the main functions of the
OTOflex 100. GN Otometrics A/S recommends that you make your-
self familiar with the following issues:
Installation
The sections Section 2.1, ‘Unpacking” on page 11, Section 2.3, ‘Views
of the OTOflex 100” on page 12, and Section 2.5, ‘Assembly and in-
stallation” on page 15 contain a full description of unpacking in-
structions, controls and socket connections, and how to install the
device.
Safety
This User Manual contains information and warnings which you
must follow at all times to ensure the safe performance of the
OTOflex 100. Local government rules and regulations, if applicable,
should also be followed at all times.
Please see the overview of device labelling in Section 2.3, ‘Views of
the OTOflex 100” on page 12 and read the warning notes in Section
10.2, ‘Warning notes” on page 69.
Training
It is recommended that you read this manual before you start oper-
ating the OTOflex 100 so that you become familiar with the device
before testing on a patient.
Maintenance and cleaning
For instructions on how and when to clean the OTOflex 100, please
see Chapter 8, “Service and Maintenance” on page 57.

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OTOflex 100 User Manual
1.4 Typographical conventions
1.4.1 The use of WARNING, CAUTION and NOTE
For safety reasons and appropriate use of the OTOflex 100, the man-
ual contains WARNINGS, CAUTIONS and NOTES, which you
should read carefully. The use of these is defined as follows:
WARNING:
A warning indicates that there is risk of danger to persons and/or
device.
Caution:
A caution indicates that there is risk of damage to the device.
Note:
A note indicates that you should take special notice.
1.4.2 Navigation
Buttons you must press and screen functions you must select are
shown in bold type, as for instance in:
• Scroll to the Test icon on the Main Menu and press Select.
For details on navigating see Section 2.6, ‘Display & keypad” on
page 21, for entering and editing data see Section 2.6.2, ‘Entering
and editing data and settings” on page 21.

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User Manual OTOflex 100